Breast Implant Scandal in France: What Does it Mean for the U.S.?

Posted On : 01-27-2012

Do you have breast implants? How would you feel if your information—and that of every other woman in the U.S. who has had breast augmentation—was entered into a nationwide registry to keep track of you? Though it may sound a little strange (not to mention invasive), it’s possible that that will happen in the near future. It’s all in the name of protecting your health, however (not about invading your privacy!)—and it may be a better idea than it sounds like at face value.

The purpose of a national breast implant registry in the U.S. would be to give the FDA a way to track the number of complications (like leaking or infection) that women who have had breast augmentation experience as a result of their implants in the years following their surgery.

The idea of a registry has been brought up before; but the reason it’s a hot topic right now is due to a scandal involving a French company who makes implants. The company, Poly Implant Prothese (PIP), was recently exposed as having made hundreds of thousands of implants with a cheap industrial-grade silicone in order to cut their costs and drive up profits. In December, French authorities made an announcement advising all women who had PIP implants to have them removed, citing inflammation, scarring and fibrosis as possible issues if these low-quality implants were to rupture.

Luckily, PIP implants have never been approved for use in the U.S. The scandal in France, however, has raised a bigger question: Are we doing enough here to ensure the safety of our patients? At the moment, the only ones monitoring information about long-term experiences after augmentation are the companies who make the implants, like Allergan and Mentor, and the data isn’t as complete as it could be. The FDA did some investigating last year, and decided that the breast implants used in the U.S. are safe—but it could be nice to have more information, and a registry would give us that opportunity.

So far no decision has been made about starting a registry; and even if it does happen, it won’t necessarily be mandatory—so if you’re a private person, don’t get upset about it quite yet! In the meantime, the best thing you can do is make sure you do everything you can on a personal level to take care of your implants yourself, including getting an MRI every so often. And, of course, feel free to contact us here at the San Francisco Plastic Surgery & Laser Center if you have any questions or concerns.